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Not Yet Recruiting NCT07772232

Comparison of Holmium Laser Enucleation of the Prostate and Robotic Water Jet Ablation for Benign Prostatic Hyperplasia

Conditions: Benign Prostate Hypertrophy(BPH), Lower Urinary Track Symptoms

Sex: Male
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: The Methodist Hospital Research Institute

Location: Houston Methodist Houston Texas

Summary

This study compares two FDA-approved surgical treatments for benign prostatic hyperplasia (BPH): Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES 2.0 technology and Robotic Water Jet Ablation (RWJA) using the Hydros Robotic System. Men with BPH and prostate volumes between 50 and 180 mL will be randomly assigned to one of the two procedures. The study will measure changes in prostate volume, PSA, urinary flow, and bladder emptying at 12 months, along with safety, sexual function, continence, and healthcare utilization outcomes, which will be followed for up to 5 years after surgery.

Eligibility Criteria

Inclusion Criteria: 1. Male, age 50-80 years 2. International Prostate Symptom Score (IPSS) ≥ 12 3. Prostate size (TRUS): 50-180 mL 4. Diagnosis of LUTS due to BPH 5. Uroflow Qmax ≤ 15 mL/sec 6. Mentally capable, able to comply with study procedures, written informed consent provided 7. Able to follow study instructions and complete all required visits Exclusion Criteria: 1. BMI ≥ 42 2. History of prostate cancer 3. Suspected or history of bladder cancer 4. Active or untreated bladder stones at screening 5. Indwelling catheter for more than 3 months before baseline 6. Active urinary tract infection 7. History of urethral stricture or bladder neck stenosis 8. Damage to the external urethral sphincter 9. Previous prostate surgery or lower urinary tract surgery 10. Use of obligatory anticoagulants (if not stoppable) or known coagulopathy (except ASA 100 mg/d) 11. Contraindications to general and spinal anesthesia 12. Any condition that could interfere with study participation or outcomes, per investigator judgment 13. Lacks legal or mental capacity to consent 14. Simultaneous participation in another therapeutic urological trial 15. Known or persistent abuse of medication, drugs, or alcohol

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07772232). StuddyBuddy aggregates publicly available trial information.